{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "41704",
      "product_res_number": "Z-0677-06",
      "event_date_initiated": "2005-08-22",
      "event_date_posted": "2006-03-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "33329",
      "product_code": "MGB",
      "pma_numbers": [
        "P930038"
      ],
      "product_description": "Angio-Seal Vascular Closure Device.  Ref 610109.  6F STS Platform.  Sterilized by gamma radiation.  For single use only.  St. Jude Medical, Daig Division, Inc., Minnetonka, MN  55345-2126, USA.",
      "code_info": "Lot number 1146548",
      "firm_fei_number": "2182269",
      "recalling_firm": "St. Jude Medical / Daig Division",
      "address_1": "14901 Deveau Pl",
      "city": "Minnetonka",
      "state": "MN",
      "postal_code": "55345-2126",
      "additional_info_contact": "Thomas J. Pepin\n952-351-1758",
      "reason_for_recall": "Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.",
      "root_cause_description": "Other",
      "action": "Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.",
      "product_quantity": "4160",
      "distribution_pattern": "International Only-Belgium, China, Guadalajara, New Zealand and Thailand.",
      "openfda": {
        "pma_number": [
          "P100013",
          "P050007",
          "P050043",
          "P930038",
          "P020035",
          "P120016",
          "P150006",
          "P990037",
          "P080029",
          "P180025",
          "P230038",
          "P210017",
          "P010049",
          "P040022",
          "P150022",
          "P040044",
          "P920004",
          "P960043"
        ],
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        ],
        "device_name": "Device, Hemostasis, Vascular",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}